Shayne C. Gad - Safety evaluation of medical devices

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SafetyEvaluation of MedicalDevices

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Shayne Cox Gad

Gad Consulting Services

Raleigh, North Carolina

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ISBN: 0-8247-9827-9

The publisher offers discounts on this book when ordered in bulk quantities. For moreinformation, write to Special Sales/Professional Marketing at the address below.

This book is printed on acid-free paper.

Copyright 1997 by Marcel Dekker, Inc. All rights reserved.

Neither this book nor any part may be reproduced or transmitted by any form or byany means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission inwriting from the publisher.

Marcel Dekker, Inc.

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Current printing (last digit):

10 9 8 7 6 5 4 3 2 1

PRINTED IN THE UNITED STATES OF AMERICA

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To Joyce, my partner and best friend, for all the patience, encouragement,and support she has given me.

And to my father for all the love and wisdom he provided while here.

I miss you, Dad.

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Safety Evaluation of Medical Devices has been written with the sole objective ofproviding a practical guide for those who are responsible for, or concerned with, ensuringthe safety of medical devices for patients, health care providers, and those involved intheir manufacture. As such, the basic aspects of device regulation and materials utilizedin devices have been addressed. In areas where it was deemed appropriate, the historyand underlying science have also been presented to allow the reader to make moreinformed decisions.

This volume attempts to present a road map for the device and device materialsafety evaluation process as part of the overall development of new products. It reflectsthe experience and judgment of the author. It is my hope that it provides a utilitarianyet scientifically valid path through the everyday challenges of safety evaluation forall those involved.

I owe the greatest thanks to Joyce Todd for her help in proofreading this manuscript,as well as assisting me with the word processing. I am also grateful to Roger's WordService and Janine Maves for decoding my handwriting and turning out excellent firsttyped drafts of the manuscript, and to the Touchberry Group for producing finishedgraphics.

Shayne Cox Gad

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